Location: Navi Mumbai, Maharashtra, India – 400706
Company: Teva Pharmaceuticals
Job ID: 67021
Department: Regulatory Affairs – Submission Management
Experience Required:
B.Pharm Candidates: Minimum 2 Years of Regulatory Affairs Experience
M.Pharm / Master of Life Sciences Candidates: 0–1 Year Experience
Freshers: Eligible only for M.Pharm or Master of Life Sciences profiles with relevant knowledge in Regulatory Affairs and eCTD publishing
About Teva Pharmaceuticals
Teva Pharmaceuticals is one of the world’s leading pharmaceutical companies, combining a strong generics business with innovative specialty medicines. The company focuses on improving patient lives globally through advancements in neuroscience, immunology, and high-quality healthcare solutions.
Teva offers a collaborative and growth-oriented work environment where professionals can build long-term careers in Regulatory Affairs, Clinical Research, Pharmacovigilance, and Pharmaceutical Operations.
Job Overview
Teva Pharmaceuticals is hiring for the position of Regulatory Affairs Specialist II in Navi Mumbai. This opportunity is ideal for candidates with experience in eCTD publishing, regulatory submissions, lifecycle management, and global regulatory operations.
The selected candidate will work closely with Regulatory Affairs teams to ensure high-quality submission publishing, compliance with international regulatory standards, and timely submission dispatch to global health authorities including the US, EU, and Canada.
Key Responsibilities
Publish and dispatch complex eCTD regulatory submissions for US, EU, and Canada markets
Handle post-approval and lifecycle management submissions with high accuracy and compliance
Perform document-level publishing activities and quality control checks for submission-ready documents
Troubleshoot technical publishing and formatting issues as per agency requirements
Collaborate with scientific and regulatory teams for submission planning and execution
Maintain updated knowledge of global publishing standards and regulatory guidelines
Ensure compliance with ICH, eCTD, NeeS, and paper submission specifications
Work with regulatory publishing systems and document management platforms efficiently
Coordinate with Regulatory Affairs Associates to meet submission timelines and quality standards
Required Skills and Qualifications
Educational Qualification
B.Pharm
M.Pharm
Master’s Degree in Life Sciences
Experience Requirement
B.Pharm candidates must have at least 2 years of Regulatory Affairs experience
M.Pharm or Life Sciences postgraduates with 0–1 year experience may apply
Freshers with strong understanding of Regulatory Affairs publishing concepts may be considered for junior-level responsibilities
Technical Skills
Candidates should have knowledge or exposure to:
eCTD Publishing
Regulatory Submission Management
Lifecycle Management Submissions
ICH Guidelines
NeeS and eCTD Specifications
Regulatory Documentation Standards
Preferred Software Knowledge
Veeva Vault
Global Insight
ISI Toolbox
Adobe Acrobat
Lorenz Validator
Additional Skills
Strong English communication skills
Attention to detail and documentation accuracy
Ability to work in a global and multicultural environment
Good understanding of regulatory IT systems and publishing workflows
Why Join Teva Pharmaceuticals?
Opportunity to work with a globally recognized pharmaceutical organization
Exposure to international regulatory submissions and global health authority standards
Career growth opportunities in Regulatory Affairs and Regulatory Operations
Inclusive work culture with learning and development support
Flexible and employee-focused work environment
Access to internal career development platforms and global mobility opportunities
Reporting To
Manager – Regulatory Submission Management
Equal Employment Opportunity
Teva Pharmaceuticals is committed to creating an inclusive and diverse workplace. The company provides equal employment opportunities regardless of race, gender, disability, religion, nationality, age, sexual orientation, or other protected categories under applicable laws.
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